Director/Sr. Director Regulatory CMC, Lilly Gene Therapy
LI Test Company(1 month ago)
About this role
The Director/Senior Director, Regulatory CMC will lead regulatory CMC strategy for Eli Lilly’s gene therapy portfolio, shaping regulatory pathways from early development through commercialization. This senior role ensures global compliance with health authority requirements and partners closely with cross-functional teams to inform product development and lifecycle decisions.
Required Skills
- Regulatory Strategy
- CMC
- Submissions
- Health Authorities
- Gene Therapy
- Manufacturing
- Analytical Methods
- Cross-Functional Leadership
- Risk Management
- Communication
+2 more
Qualifications
- Bachelor's Degree in Scientific Discipline
- MS
- PhD
About LI Test Company
lilly.comEli Lilly and Company is a global biopharmaceutical company headquartered in Indianapolis, Indiana. It discovers, develops, manufactures and commercializes prescription medicines across therapeutic areas including diabetes, oncology, immunology, neuroscience and pain, and has a longstanding history in insulin and other major drug discoveries. Lilly invests heavily in research and clinical development and partners with biotech, academic institutions, and industry collaborators to advance biologics, small molecules, and precision medicines. The company operates global manufacturing and commercial networks and provides patient-support programs to improve access to its therapies.
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